A Clinical Study to Evaluate the Pharmacokinetics of Testosterone Gel Using an Applicator

A Phase 2, Open-Label, Sequential Dose Escalation Study in Adult Hypogonadal Males to Evaluate the Pharmacokinetics of Three Volumes of FE 999303 (Testosterone Gel), Applied to the Shoulder/Upper Arm, Using an Applicator Compared With Hand Application

This is a Phase 2 clinical trial in adult hypogonadal males with baseline morning serum testosterone concentrations <300 ng/dL. The purpose of this study is to evaluate the pharmacokinetics of FE 999303, delivered using an applicator in comparison to hand application

Inclusion Criteria:

• Ages 18-75
• History of hypogonadism
• In good health based on medical history, physical examination, and clinical laboratory tests
• Serum testosterone deficiency
• One or more symptom(s) of testosterone deficiency (i.e. fatigue, reduced libido, or reduced sexual functioning)
• Body mass index (BMI) between 18 and 35 kg/m^2
• All screening lab tests within 20% of the normal range (exceptions are liver function tests)
• HIV, Hepatitis B and C negative

Exclusion Criteria:

• Previous use of FE 999303
• Prostate cancer
• Breast carcinoma, patient or partner
• Palpable prostatic mass(es)
• Serum PSA levels ≥3 ng/dL
• Chronic use of any drug of abuse
• Lower urinary tract obstruction
• Clinically significant anemia or renal dysfunction
• Cardiovascular disease
• Hyperparathyroidism or uncontrolled diabetes
• Generalized skin irritation or significant skin disease
• Use of any medications that could be considered anabolic (e.g. dehydroepiandrosterone (DHEA)) or could interfere with androgen metabolism (e.g. spironolactone, 5-alfa-reductase-inhibitors, ketoconazole, abiraterone)
• Use of estrogens, GnRH agonists/antagonist, antiandrogens, human GH (within previous 12 months of screening)
• Use of testosterone products (within 8 weeks of screening for parenteral products, or 6 weeks of screening for other preparations)
• Sleep apnea
• Untreated depression
• Subject with a partner who is pregnant or will not use contraception